Division: Siemens Healthineers
Business Unit: Controlling and Finance
Requisition Number: 231828
Primary Location: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 20%
Siemens US Talent Acquisition
Assay Risk Lead
This position requires an individual with knowledge of external risk management regulations, i.e., ISO 14971 and a demonstrated ability to implement risk management to in vitro diagnostic assay products in a compliant and efficient manner. The individual in this role will serve as the functional lead and subject matter expert (SME) for risk management for assay products, working closely with assay development colleagues to support all risk related activities. This position reports into Assay Development R&D.
To ensure that risk management for assay products is effectively deployed and sustained.
Specific responsibilities include:
Risk Coach and Trainer
Apply assay product knowledge to risk management activities within the Assay Development group.
Lead existing assay product risk file remediation efforts to meet In Vitro Diagnostic Regulation (IVDR) requirements and to support new instrument projects.
Advise Assay Development personnel on risk management activities throughout the product lifecycle. This includes risk management plans and reports, hazard analysis, design and process risk assessments.
Ensure product line risk files are updated per defined schedules and aligned with changes to external or internal risk guidance.
Drive continuous improvement efforts through facilitating, leading and collaborating with cross functional teams.
Represent assay development during internal and external audits on matters related to risk management
Required Knowledge/Skills, Education, and Experience
A minimum of 10 years in the diagnostics industry with at least 5 years of demonstrated experience and proficiency with assay development. A minimum of 3 years demonstrated experience with Risk Management.
Knowledge and Skills:
Excellent understanding and practical application of medical device quality system regulations, in particular ISO 14971.
Excellent verbal and written communication skills
Strong interpersonal skills and ability to lead teams
Excellent problem solving skills
Ability to understand and apply assay product knowledge
Ability to recognize problems and take corrective measures
Experience with risk management processes and tools
Experience with in vitro medical devices
Ability to query and analyze technical, scientific and medical information
Ability to communicate results and propose recommendations to a technical audience of varying skill levels
Excellent project management skills
Ability to manage multiple ongoing tasks, be responsive to critical situations and changing priorities
Ability to work independently; self-motivation is a must